Medical Device Project Manager - Capital Expansion
Medical Device Project Manager – Capital Expansion
Our client is a large manufacturer of Medical Supplies, Bottling, Tubing Extrusion and various reconstitution devices. Primary focus will also be on leading project teams through the identification, justification, prioritization, initiation, development and implementation, construction, commissioning/startup and qualification/validation processes for a capital expansion project of one or more manufacturing lines. Cross-functional project management will be involved in this role as well.
Principle Duties and Responsibilities:
The ideal candidate will have 7-10+ years of medical device manufacturing experience. Manage day-to-day Project Management activities. The capital equipment has been identified and is the in the process of being purchased. This person will be responsible for things including but not limited to:
- Manage Start-up, debug, and commission new manufacturing processes.
- Responsible for adhering to FDA Design Control standards at all times.
- Take leadership role in driving a cross-functional team (Manufacturing, Engineering, Quality Control, Validation, Regulatory)
- Identify and engage necessary resources/stakeholders to gain commitment.
- Drive Change - Identify barriers, recommend and implement solutions.
- Drive Results - Lead project team, develop project plans, and execute to established timelines.
- Drive Communication – Present project status updates to senior management & stakeholders.
- Minimum 10 years Engineering / Manufacturing experience, including design, construction, commissioning/startup, qualification/validation. Medical Device manufacturing required.
- Minimum 5 years of project management experience in product life cycle management, with demonstrated success leading multi-site projects
Job Type: Contract